Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
Primary Purpose
Multiple Sclerosis, Relapsing-Remitting
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
dimethyl fumarate
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Pediatrics
Eligibility Criteria
Key Inclusion Criteria:
- Ability of parents, legal guardians, and/or subjects to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. Subjects will provide assent in addition to the parental or guardian consent, as appropriate, per local regulations.
- Subjects who completed, as per protocol, the previous BG00012 clinical study 109MS202 (NCT02410200) and remain on BG00012 treatment.
Key Exclusion Criteria:
- Unwillingness or inability to comply with study requirements, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
- Any significant changes in medical history occurring after enrollment in the parent Study 109MS202 (NCT02410200), including laboratory test abnormalities or current clinically significant conditions that in the opinion of the Investigator would have excluded the subject's participation from the parent study. The Investigator must re-review the subject's medical fitness for participation and consider any factors that would preclude treatment.
- Subjects from Study 109MS202 (NCT02410200) who could not tolerate study treatment.
NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
dimethyl fumarate
Arm Description
Participants will receive 120 mg capsule(s) taken orally.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence that does not necessarily have a causal relationship with treatment. An SAE is any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.
Number of Participants Discontinuing Treatment Due to an Adverse Event
An AE is any untoward medical occurrence that does not necessarily have a causal relationship with treatment.
Secondary Outcome Measures
Total Number of New or Newly Enlarging T2 Hyperintense Lesions From Week 16 to Week 24
T2 hyperintense lesions were measured by MRI brain scans.
Total Number of New or Newly Enlarging T2 Hyperintense Lesions From Week 64 to Week 72
T2 hyperintense lesions were measured by MRI brain scans.
Average Annualized Relapse Rate (ARR)
Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Investigator. New or recurrent neurologic symptoms that evolved gradually over months were considered disability progression, not an acute relapse, and were not treated with steroids.
The ARR was calculated as the total number of relapses that occurred during the previous 12 months and during the 120 weeks on treatment for participants in Study 109MS202 that continued into Study 109MS311, divided by the total number of person-years followed prior to the study and by the total number of person-years followed during the study, respectively.
Percentage of Participants Experiencing One or More Relapses
Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Investigator. New or recurrent neurologic symptoms that evolved gradually over months were considered disability progression, not an acute relapse, and were not treated with steroids.
Change From Baseline in the Degree of Disability
The Expanded Disability Status Scale (EDSS) measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
Number of Participants Experiencing Disability Progression
Measured by at least a 1.0-point increase on the EDSS from baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from baseline EDSS = 0 that is sustained for 24 weeks.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02555215
Brief Title
Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
Official Title
A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 22, 2016 (Actual)
Primary Completion Date
September 24, 2018 (Actual)
Study Completion Date
September 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects who completed Study 109MS202 (NCT02410200). Secondary objectives are as follows: To evaluate the long-term efficacy of BG00012 and to describe the long-term Multiple Sclerosis (MS) outcomes in subjects who completed Study 109MS202 (NCT02410200).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
Pediatrics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dimethyl fumarate
Arm Type
Experimental
Arm Description
Participants will receive 120 mg capsule(s) taken orally.
Intervention Type
Drug
Intervention Name(s)
dimethyl fumarate
Other Intervention Name(s)
DMF, BG00012
Intervention Description
administered orally
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE is any untoward medical occurrence that does not necessarily have a causal relationship with treatment. An SAE is any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.
Time Frame
Baseline to Week 96
Title
Number of Participants Discontinuing Treatment Due to an Adverse Event
Description
An AE is any untoward medical occurrence that does not necessarily have a causal relationship with treatment.
Time Frame
Baseline to Week 96
Secondary Outcome Measure Information:
Title
Total Number of New or Newly Enlarging T2 Hyperintense Lesions From Week 16 to Week 24
Description
T2 hyperintense lesions were measured by MRI brain scans.
Time Frame
Week 16 to Week 24
Title
Total Number of New or Newly Enlarging T2 Hyperintense Lesions From Week 64 to Week 72
Description
T2 hyperintense lesions were measured by MRI brain scans.
Time Frame
Week 64 to Week 72
Title
Average Annualized Relapse Rate (ARR)
Description
Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Investigator. New or recurrent neurologic symptoms that evolved gradually over months were considered disability progression, not an acute relapse, and were not treated with steroids.
The ARR was calculated as the total number of relapses that occurred during the previous 12 months and during the 120 weeks on treatment for participants in Study 109MS202 that continued into Study 109MS311, divided by the total number of person-years followed prior to the study and by the total number of person-years followed during the study, respectively.
Time Frame
Baseline to Week 96
Title
Percentage of Participants Experiencing One or More Relapses
Description
Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Investigator. New or recurrent neurologic symptoms that evolved gradually over months were considered disability progression, not an acute relapse, and were not treated with steroids.
Time Frame
Baseline to Week 96
Title
Change From Baseline in the Degree of Disability
Description
The Expanded Disability Status Scale (EDSS) measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
Time Frame
Baseline to Week 96
Title
Number of Participants Experiencing Disability Progression
Description
Measured by at least a 1.0-point increase on the EDSS from baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from baseline EDSS = 0 that is sustained for 24 weeks.
Time Frame
Baseline to Week 96
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Ability of parents, legal guardians, and/or subjects to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. Subjects will provide assent in addition to the parental or guardian consent, as appropriate, per local regulations.
Subjects who completed, as per protocol, the previous BG00012 clinical study 109MS202 (NCT02410200) and remain on BG00012 treatment.
Key Exclusion Criteria:
Unwillingness or inability to comply with study requirements, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
Any significant changes in medical history occurring after enrollment in the parent Study 109MS202 (NCT02410200), including laboratory test abnormalities or current clinically significant conditions that in the opinion of the Investigator would have excluded the subject's participation from the parent study. The Investigator must re-review the subject's medical fitness for participation and consider any factors that would preclude treatment.
Subjects from Study 109MS202 (NCT02410200) who could not tolerate study treatment.
NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Research Site
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Research Site
City
Hradec Kralove
ZIP/Postal Code
50333
Country
Czechia
Facility Name
Research Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80337
Country
Germany
Facility Name
Research Site
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Research Site
City
Kuwait City
ZIP/Postal Code
15462
Country
Kuwait
Facility Name
Research Site
City
Riga
ZIP/Postal Code
LV-1004
Country
Latvia
Facility Name
Research Site
City
Beirut
ZIP/Postal Code
1107 2020
Country
Lebanon
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
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